BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3063255 · Received March 27, 2013

    Report

    Report Number
    9616066-2013-00222
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 7, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED LEAK. THE SET WAS DISCARDED BECAUSE IT WAS CONTAMINATED. THE ROOT CAUSE OF THE FAILURE COULD NOT BE IDENTIFIED. A CAREFUSION REPRESENTATIVE VISITED THE CUSTOMER AND DETERMINED THE CUSTOMER WAS NOT TIGHTENING CONNECTIONS PRIOR TO PRIMING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TUBING CAME APART AND LEAKED. THE PT WAS DRAPED FOR A ROBOTIC PROCEDURE WHEN THE EVENT OCCURRED. THE TUBING LEAKED AT THE JUNCTION NEAREST THE PT. THIS WAS A PT WITH A KNOWN BLOOD BORN DISEASE AND WHEN THE SET SEPARATED, BLOOD LEAKED OUT ONTO THE BEDDING (UNDER SURGICAL DRAPES). THE LEAKED BLOOD WENT UNNOTICED FOR A UNDEFINED PERIOD OF TIME. THERE WERE NO OTHER PT OR EVENT DETAILS PROVIDED. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HARM TO THE PT OR CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126638 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 11059729 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK